We are seeking a Manager, Quality Assurance - Bioanalysis to join IQVIA Laboratories in Indianapolis, Indiana.
We hire passionate innovators who drive healthcare forward through thoughtful and inclusive collaboration. If you want to discover a career with greater purpose, join us as we transform and accelerate research and development.
As a Manager, Quality Assurance - Bioanalytics, you will oversee and coordinate assigned QA programs in support of customer accounts, functional accounts, audit and inspection programs, or QA quality management systems at a regional and/or global level. You will provide support to management with insights, analyses, and support in the assessment and promotion of compliance with regulations, guidelines, and operating procedures, risk identification and mitigation, quality, process, and productivity/efficiency improvement initiatives. You will also act as a line manager for one or more QA staff and oversee staff development and team deliverables.
What youâll be doing:
Providing guidance, interpretation, support, training, and key input to development groups for consultation and interpretation of regulations, guidelines, corporate standards, and policies.
Overseeing and participating in the documentation, reporting, and closure of compliance issues.
Organizing and delivering training to other IQVIA departments concerning the activities of Quality services, results of activities, quality initiatives, GXP, etc.
Ensuring the follow-up of major and critical audit findings to ensure that appropriate actions have been taken and have adequately resolved the issues identified.
Evaluating policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements.
Serving as author of Quality Assurance Standard Operating Procedures (SOPs) as assigned.
Advising Quality Assurance management on system audit needs.
Ensuring the Quality Assurance database is maintained and up to date to reflect the status of audits being scheduled, auditor assignment, and audit reporting and/or follow-up status.
What we are looking for:
Bachelor's Degree Preferred.
7 years of Quality Assurance experience in pharmaceutical, technical, or related areas, including GCP Quality Assurance experience.
5 years of management experience.
Or other equivalent combination of education, training, and experience may be accepted in lieu of degree.
The knowledge, skills, and abilities needed for this role:
An excellent knowledge of current GXP regulations and guidelines, and associated regulatory requirements.
Knowledge of word-processing, spreadsheet, and database applications.
Extensive knowledge of pharmaceutical research and development processes and regulatory environments.
Considerable knowledge of quality assurance processes and procedures.
What we offer you:
We put our employees at the center of everything we do and are committed to providing them, and their families, with benefits that meet their diverse and changing needs. We invest in integrated benefits programs and resources to take care of our employeesâ physical, mental, emotional, financial, and social well-being so they can thrive at home and at work, at any stage of their well-being journey.
To learn more about our benefits, visit https://jobs.iqvia.com/benefits.
If youâre looking to unleash your potential, join IQVIA Laboratories to help make the extraordinary possible!
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
The potential base pay range for this role, when annualized, is $75,400.00 - $188,600.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.iqvia